EC-CERTIFICATE (Production quality assurance) This is to certify that the company Xenopus Inc. 2 Prospect Road Morrisburg, Ontario K0C 1X0 Canada has implemented and maintains a quality assurance system which applies to the manufacture and final controls of the products. Through an audit, documented in a report, performed by DQS Medizinprodukte GmbH, it was verified that the management system fulfills the requirements of Annex V of Council Directive 93/42/EEC concerning medical devices with respect to the following medical devices: Dental rotary instruments: Diamond burs, class IIa Carbide burs, class IIa The manufacturer is subject to surveillance according to Annex V, Section 4. The CE marking with the Notified Body Identification Number (0297) may be affixed on the devices listed in the certificate. The certificate is in the case of class I(s) devices (I(s) = class I products placed on the market in sterile conditions) limited to the aspects of manufacture concerned with securing and maintaining sterile conditions. The certificate is in the case of class I(m) devices (I(m) = class I devices with a measuring function) limited to the aspects of manufacture concerned with the conformity of the products with the metrological requirements. Certificate registration no. Effective date Expiry date Dr. Thomas Feldmann Head of Certification Body August-Schanz-Straße 21, 60433 Frankfurt am Main, Tel. +49 (0) 69 95427-300, [email protected] DQS Medizinprodukte GmbH is a Notified Body according to Council Directive 93/42/EEC concerning medical devices with the Identification Number 0297. Sigrid Uhlemann Managing Director